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The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Suspended
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Individual Exercise
Group Exercise
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring exercise, fracture risk

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Multiple Myeloma after primary Treatment
  • Sufficient knowledge of the German language to being able to follow the study procedures
  • Cardiologic-internal clearance for exercise

Exclusion Criteria:

  • Fulfillment of absolute exclusion criteria of the cardiovascular system or on the musculoskeletal system with regard to physical trainability
  • Insufficient language knowledge
  • Cognitively unable to follow the course of the study
  • Severe mental illness

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Risk - Individual Exercise

Low Risk - Group Exercise

Arm Description

Patients who show an increased fracture risk and/or increased risk of fall in the screening assessments and are therefore allocated to an individualized personal training.

Patients who show neither increased fracture risk nor increased risk of fall in the screening assessments and are therefore allocated to the exercise group.

Outcomes

Primary Outcome Measures

Feasibility (Adherence)
We hypothesize that the adherence of "High Risk Patients" to a personal, individualized exercise intervention is equal to that of "Low Risk Patients" performing group exercise.

Secondary Outcome Measures

VO2max
Maximum oxygen consumption in a cardiopulmonary exercise testing
Handgrip Strength (HGS)
Handgrip Dynamometer (JAMAR)
Six Minute Walk Test (6MWT)
Distance covered when walking as fast as possible in six minutes
Tinetti-Test/Performance Oriented Mobility Assessment (POMA)
Risk of Fall Assessment
Timed up and Go Test (TUG)
Risk of Fall Assessment
Bioimpedance Analysis (BiA)
Body Composition measurement measured with Nutribox (BiA)
Five Repetitions Sit-to-Stand Test (5STS)
Test for Lower Extremity Strength (time needed to stand up and sit down on a chair 5 times)

Full Information

First Posted
March 2, 2020
Last Updated
October 18, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04300335
Brief Title
The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma
Official Title
The Feasibility and Effects of an Individualized Aerobic and Resistance Training Protocol for Patients Suffering From Multiple Myeloma With Varying Risk of Fall and Fracture - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Due to COVID-19 and the fact that the study participants are part of the "high-risk" population, the start of the recruiting process has been delayed at will.
Study Start Date
March 2024 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multiple myeloma is the second most common haematological cancer with a cancer incidence of around 500 new cases in Austria per year . Novel treatment methods have significantly increased the cancer-specific survival rate in patients with multiple myeloma. For Austria, this means that 5- and 10-year survival rates rose from 32.1 to 46.4% and from 19.0 to 25.6% from the end of the 1980s to the end of the 2000s. Longer survival is associated with the need to maintain independence and quality of life in the longer term. In this context, regular physical training has seen a significant increase in the importance of cancer in recent years.The guidelines of the American College of Sports Medicine still contain very general training recommendations for cancer patients. Either 150 minutes of moderate or 75 minutes of intensive endurance training per week are recommended, supplemented by at least two units of strengthening training and stretching exercises for the large muscle groups. In a recent cross-sectional and pilot study with multiple myeloma patients that was carried out at the Clinic for Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna (EK 1725/2018), it was on the one hand identified that there was a discrepancy between these patients on the one hand has given actual and perceived risk of falling, and on the other hand it is concluded that training recommendations should be carried out separately in group and individual training according to the actual risk of falling and fracture. The present project is the follow-up to this cross-sectional investigation. The aim is to examine the feasibility and effects of a structured, physical training program carried out over a period of 12 weeks on physical performance, quality of life, body composition and the risk of falling. The effects of patients with increased risk in individual training sessions are compared to those of lower risk patients in group training sessions. Furthermore, the study patients will be able to bring training partners with them to their own training units if available and for their own security. They are evaluated separately according to qualitative criteria.
Detailed Description
The aim of this study is to investigate the feasibility and effectiveness of individualized training support for multiple myeloma patient populations divided into high and low risk according to their fall and fracture risk. The primary hypothesis is that multiple myeloma patients who meet the criteria for a high risk of falling and / or fracture can achieve equivalent adherence rates and training effects through individually compiled individual training, such as multiple myeloma patients with low risk of falling who conduct group training. The adherence rates are recorded via attendance lists for training and video conferences as well as a training diary for independent training. To record the training effects, physical performance and functionality are measured and the quality of life, sexuality, depression, fatigue, sleep quality, work ability and risk of falling are assessed using standardized, validated questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
exercise, fracture risk

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Individual exercise prescription (high fracture risk and/or high risk of fall patients) Group 2: Group exercise (low fracture risk and low risk of fall patients)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Risk - Individual Exercise
Arm Type
Experimental
Arm Description
Patients who show an increased fracture risk and/or increased risk of fall in the screening assessments and are therefore allocated to an individualized personal training.
Arm Title
Low Risk - Group Exercise
Arm Type
Experimental
Arm Description
Patients who show neither increased fracture risk nor increased risk of fall in the screening assessments and are therefore allocated to the exercise group.
Intervention Type
Other
Intervention Name(s)
Individual Exercise
Intervention Description
Supervised body weight & resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise
Intervention Type
Other
Intervention Name(s)
Group Exercise
Intervention Description
Supervised body weight & resistance band resistance exercises in a Group setting plus home based aerobic exercise
Primary Outcome Measure Information:
Title
Feasibility (Adherence)
Description
We hypothesize that the adherence of "High Risk Patients" to a personal, individualized exercise intervention is equal to that of "Low Risk Patients" performing group exercise.
Time Frame
Adherence rates through 12 weeks of exercise intervention program
Secondary Outcome Measure Information:
Title
VO2max
Description
Maximum oxygen consumption in a cardiopulmonary exercise testing
Time Frame
Baseline + 12 weeks
Title
Handgrip Strength (HGS)
Description
Handgrip Dynamometer (JAMAR)
Time Frame
Baseline + 12 weeks
Title
Six Minute Walk Test (6MWT)
Description
Distance covered when walking as fast as possible in six minutes
Time Frame
Baseline + 12 weeks
Title
Tinetti-Test/Performance Oriented Mobility Assessment (POMA)
Description
Risk of Fall Assessment
Time Frame
Baseline + 12 weeks
Title
Timed up and Go Test (TUG)
Description
Risk of Fall Assessment
Time Frame
Baseline + 12 weeks
Title
Bioimpedance Analysis (BiA)
Description
Body Composition measurement measured with Nutribox (BiA)
Time Frame
Baseline + 12 weeks
Title
Five Repetitions Sit-to-Stand Test (5STS)
Description
Test for Lower Extremity Strength (time needed to stand up and sit down on a chair 5 times)
Time Frame
Baseline + 12 weeks
Other Pre-specified Outcome Measures:
Title
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Basic Module (EORTC QLQ-C30)
Description
Cancer specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time Frame
Baseline + 12 weeks
Title
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma Module (EORTC QLQ-MY20)
Description
Multiple myeloma specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time Frame
Baseline + 12 weeks
Title
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ-FA12)
Description
Cancer related fatigue specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time Frame
Baseline + 12 weeks
Title
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Sexual Health Quality Module (EORTC QLQ-SHQ22)
Description
Cancer related sexual health specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time Frame
Baseline + 12 weeks
Title
International Physical Activity Questionnaire (IPAQ)
Description
Physical Activity (Questionnaire); Patients are asked about the frequency and volume of at least 10 minutes long episodes of vigorous and moderate physical activity during their last 7 days. Higher values indicate higher levels of physical activity.
Time Frame
Baseline + 12 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Anxiety and Depression (Questionnaire); Score range from 0-21; lower scores indicating lower levels anxiety and depression
Time Frame
Baseline + 12 weeks
Title
Work Ability Index (WAI)
Description
Work Ability (Questionnaire); Score range 1-10; higher scores indicating higher work ability
Time Frame
Baseline + 12 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep Quality (Questionnaire); score range from 0 to 21; lower scores indicating healthier sleep quality
Time Frame
Baseline + 12 weeks
Title
Falls Efficacy Scale (FES)
Description
Fall Risk Assessment (Questionnaire); score range from 16 to 64; higher values indicate less fall-related self-efficacy (and more concern about falling).
Time Frame
Baseline + 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Multiple Myeloma after primary Treatment Sufficient knowledge of the German language to being able to follow the study procedures Cardiologic-internal clearance for exercise Exclusion Criteria: Fulfillment of absolute exclusion criteria of the cardiovascular system or on the musculoskeletal system with regard to physical trainability Insufficient language knowledge Cognitively unable to follow the course of the study Severe mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Crevenna, Prof. MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
30539278
Citation
Radocha J, Hajek R, Brozova L, Pour L, Spicka I, Minarik J, Gregora E, Jungova A, Jelinek T, Heindorfer A, Sykora M, Maisnar V. Simplified novel prognostic score for real-life older adults with multiple myeloma-registry-based analysis. Ann Hematol. 2019 Apr;98(4):951-962. doi: 10.1007/s00277-018-3568-2. Epub 2018 Dec 11.
Results Reference
background
PubMed Identifier
23569317
Citation
Warren JL, Harlan LC, Stevens J, Little RF, Abel GA. Multiple myeloma treatment transformed: a population-based study of changes in initial management approaches in the United States. J Clin Oncol. 2013 Jun 1;31(16):1984-9. doi: 10.1200/JCO.2012.46.3323. Epub 2013 Apr 8.
Results Reference
background
PubMed Identifier
24157580
Citation
Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25.
Results Reference
background
PubMed Identifier
11879296
Citation
Mock V, Pickett M, Ropka ME, Muscari Lin E, Stewart KJ, Rhodes VA, McDaniel R, Grimm PM, Krumm S, McCorkle R. Fatigue and quality of life outcomes of exercise during cancer treatment. Cancer Pract. 2001 May-Jun;9(3):119-27. doi: 10.1046/j.1523-5394.2001.009003119.x.
Results Reference
background
PubMed Identifier
30686037
Citation
Crevenna R. Aspects of cancer rehabilitation: an Austrian perspective. Disabil Rehabil. 2020 Jan;42(1):1. doi: 10.1080/09638288.2018.1522554. Epub 2019 Jan 27. No abstract available.
Results Reference
background
PubMed Identifier
26441078
Citation
Crevenna R. Cancer rehabilitation and palliative care--two important parts of comprehensive cancer care. Support Care Cancer. 2015 Dec;23(12):3407-8. doi: 10.1007/s00520-015-2977-1. Epub 2015 Oct 6. No abstract available.
Results Reference
background
PubMed Identifier
20559064
Citation
Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195.
Results Reference
background
PubMed Identifier
31784826
Citation
Cenik F, Keilani M, Hasenohrl T, Huber D, Stuhlpfarrer B, Pataraia A, Crevenna R. Relevant parameters for recommendations of physical activity in patients suffering from multiple myeloma : A pilot study. Wien Klin Wochenschr. 2020 Mar;132(5-6):124-131. doi: 10.1007/s00508-019-01582-z. Epub 2019 Nov 29.
Results Reference
background
Links:
URL
https://www.statistik.at/web_de/statistiken/menschen_und_gesellschaft/gesundheit/krebserkrankungen/plasmozytom_myelom/index.html
Description
Austrian Cancer Statistics Plasmocytoma/Myeloma

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The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma

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